Orthodontics is the specialty of dentistry that is concerned with the study and treatment of malocclusion, which can be a result of tooth irregularity, disproportionate facial skeleton relationship, or both. Orthodontics treats malocclusion through the displacement of teeth via bony remodeling and control and modification of facial bone growth.
This process has been accomplished for hundreds (even thousands) of years using static mechanical forces to induce bone remodeling, thereby enabling teeth to slowly move through bone. In modern orthodontics, an archwire interfaces with brackets that are affixed to each tooth and the two components together are called braces. As the teeth and bones respond to the pressure applied via the archwire by shifting their positions, the wires are again tightened to apply additional pressure. This widely accepted approach to treating malocclusion takes about twenty-four months on average to complete, and cannot be rushed by applying more force because of the risk of root resorption.
In addition to static forces, it was recently proposed that cyclic forces could also be used for orthodontic remodeling. Kopher and Mao assessed cyclic forces of 5 N peak-magnitude at 1 Hz in rabbits, while Peptan and Mao assessed cyclic forces of 1 N at 8 Hz in rabbits, and Vij and Mao assessed cyclic forces of 300 mN at 4 Hz in rats. In aggregate, the data from these three studies indicated that cyclic forces between 1 Hz and 8 Hz, with forces ranging from 0.3 N to 5 N, increased the rate of bone remodeling. Rates depended on different methodologies, but increases of 2.5 times with vibrational forces were common.
The early Mao studies provided a basis for both possible efficacy and likely safety for using vibration in humans to assist orthodontic tooth movement, but the animal studies needed to be repeatable in humans, and the devices used by Mao and the others were completely unsuitable for human clinical work. Furthermore, the rabbit experiments were cranial suture growth and facial length experiments, not orthodontic, and the risk of root resorption is a complicating factor in translating Mao's work to orthodontics.
OrthoAccel® Technologies Inc. invented and tested the first commercially successful dental vibrating device, as described in US2008227046 and related cases, designed to apply cyclic forces to the dentition for accelerated remodeling purposes. Both intra-oral and extraoral embodiments are described in US2008227046. The bite plate is specially designed to contact occlusal as well as lingual and/or facial surfaces of the dentition, and thus is more effective than any prior art devices in conveying vibrational forces to the teeth, transmitting vibration in two axes. Finally, the device is slim, capable of hands free operation, lacks the bulky headgear of prior art devices, and has optimized force and frequency for orthodontic remodeling. Thus, its comfort level and compliance was also found to be high, with patients reporting that they were satisfied with the device, especially after the motor was redesigned to be quieter and smoother, as described in US2010055634 et seq. In fact, this device has been marketed as AcceleDent® and AcceleDent® Aura in the United States and several other countries and has achieved remarkable commercial success since its recent introduction. Further, the device was shown in clinical trials to speed orthodontic remodeling as much as 50%, and is truly a breakthrough in orthodontic technology (Kau 2010; see also clinicaltrials.gov). AcceleDent® represents the first successful clinical approach to accelerate orthodontic tooth movement by modulating bone biology in a non-invasive and non-pharmacological manner.
As the AcceleDent® device increases in popularity, it provides a unique opportunity for the orthodontist to monitor general health status and provide early intervention. Patients using traditional orthodontics, such as braces or aligners, are already using the AcceleDent® device daily for orthodontic remodeling for a period of a year or more. Thus, if the bite plate was combined with a simple and robust diagnostic platform, the orthodontist could provide primary health status information to his or her patients. Furthermore, since dental care is typically twice a year or yearly, whilst medical visits are far less frequent, a device that combined dental/orthodontic care with diagnostic information could provide an unprecedented ability to conveniently monitor patient health status and allow early intervention.
Several patents are already directed to salivary testing for various diseases, including various cancer, oral cancer, periodontal disease, stress, and the like. See e.g., US20100196941 (periodontal); US20120028261 (periodontal); US20100210023 (oral cancer); WO2007081306 (stress); US20080183101 (oral health). However, none of these applications contemplates combining such testing with a device that is already in daily use by patients.
Indeed, periodontal disease, gingivitis and caries are likely to be of particular interest to dental practitioners. Markers for periodontal disease activity include FAS, interleukin 1 beta (IL-1B), IL-6, IL-8, IL-12A, IL-17B, DEFB4, CTSS, CARD10, BGN, BE, LCN8, lactoperoxidase (LPO), aspartate aminotransferase (AST), alkaline phosphatase (ALP), aminopeptidases, beta glucuronidase, PGE-2, MMP-8, MMP-9, MMP-13, telopeptide, osteocalcin, and CRP. Indeed, at least three substances (peroxidase, hydroxyproline and calcium) are known to be significantly increased in the saliva of patients with periodontitis.
Thus, what is needed in the art is a simple robust diagnostic platform that is combinable with mouthpieces that are already in regular use by patients.